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CompletedNCT01733979Updated Aug 26, 2019

Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia

An interventional study of Heme-Iron Polypeptide and Placebo in Anemia, sponsored by Chonbuk National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-26.

Sponsored by Chonbuk National University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Feb 2012, registered Nov 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
All
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Study summary

The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.

02

Conditions studied

  • Anemia

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03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 80 is below the median of 94 across 1,291 interventional studies indexed under Anemia.

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Lead sponsor

Chonbuk National University Hospital is the lead sponsor of 88 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males and females 19-60 years old
  • Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
  • Able to give informed consent

Exclusion criteria

Exclusion Criteria:

  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • Participation in any other clinical trials within past 2 months
  • History of alcohol or substance abuse
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
  • Pregnant or lactating women etc.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Heme-Iron Polypeptide

    Dietary Supplement: Heme-Iron Polypeptide

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

  • Active comparator
    Heme-Iron

    Dietary Supplement: Heme-Iron

  • Active comparator
    Organic Iron

    Dietary Supplement: Organic Iron

Interventions

  • Dietary supplementHeme-Iron Polypeptide

    Heme-Iron Polypeptide (1g/day)

  • Dietary supplementPlacebo

    Placebo (1g/day)

  • Dietary supplementHeme-Iron

    Heme-Iron (1g/day)

  • Dietary supplementOrganic Iron

    Organic Iron (1g/day)

06

What researchers measure

Primary outcomes

  1. Changes in hemoglobin

    Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).

    Time frame: 4 weeks

  2. Changes in transferrin saturation

    Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).

    Time frame: 4 weeks

Secondary outcomes

  1. Changes in serum iron

    Serum iron was measured in study visit 1(0 week) and visit 5(4 week).

    Time frame: 4 weeks

  2. Changes in ferritin

    Ferritin was measured in study visit 1(0 week) and visit 5(4 week).

    Time frame: 4 weeks

07

Study locations

1 site
  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
    Jeonju, Jeollabuk-do 560-822, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01733979
Lead sponsor
Chonbuk National University Hospital
Responsible party
Soo-Wan Chae (Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital) — Principal investigator
First posted
Nov 27, 2012
Start date
Feb 7, 2012
Primary completion
Nov 14, 2012
Completion
Nov 14, 2012
Last update
Aug 26, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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